The present invention is directed towards devices and methods for the treatment of medical conditions, particularly where cryotherapy or heat are recommended.
Acute sports injuries and post joint surgery is accompanied by pain and swelling. Most often the professional practitioner provides both therapeutic and analgesic modalities to treat these symptoms. The most common treatment to reduce both pain and swelling is to apply cold in the form of ice or circulating cooled water.
Ice bags are the most commonly used modality for treating acute injuries like severe strains, sprains, contusions, and concussions. There are commercial products that provide circulating cool water through wraps designed for different body parts, but these products have limited ability to control the treatment. Many commercial products are not portable and are too expensive to send home with a patient. For acute injuries the patient is most often sent home with ice bags for the remainder of the treatment.
There are many devices on the market for managing thermal treatment regiments including electric blankets, circulating cooled and heated water in blankets, pads & body part shaped garments, chemical and inert products bagged for the freezer and microwave, along with the old standby hot water bottles and ice bags.
The electric heating devices have wires channeled in fabric or flexible plastic that produce a resistance and resulting heat that is controlled by a rheostat in increase and decrease the input current.
There are sophisticated and more costly devices that are used by hospitals, and surgical care physicians. Some of the more sophisticated devices use controllers to operate refrigerating units with condensers, evaporators, and compressors to cool the circulating water and heating elements to create warm fluids. Both the cooled and warmed fluids require a pumping system to circulate the fluids through the tubing in the pad, blanket, garment or fixture used to provide the thermal treatment.
Peltier devices known as Thermoelectric coolers/modules (TEC/TEM) have been on the market for a number of years, but have been applied to industrial cooling applications and small coolers for the most part. In the late 1980's TEM's found their way into the medical device industry. Most of the applications have been for creating cooling or heating fluids for circulation through a fitted “garment”, pad or blanket for thermal treatment of injuries or post-surgery. These devices were aimed at replacing the refrigerant and heating element technology. The TEM technology eliminated the refrigeration and heating element, but still required the fluid reservoir and pumping system. These units have temperature sensors to control the temperature, but with a large mass of fluid to control, the unit can have significant temperature fluctuation. The temperature is controlled by alternating the polarity of the current to the TEM based on the temperature sensor's reading. Due to the volume of fluid needed to reach temperature and the potential for heat exchanged (loss or gain) through the insulated garment, it takes significant time for the fluid in the reservoir to reach and maintain the desired temperature.
Additionally, a larger TEM and more energy is required than with direct TEM treatment to the targeted area through a thermal conductive substrate placed directly on area of treatment.
The circulating fluid cannot penetrate the treatment site as quickly nor reach the critical temperature as rapidly. If temperatures of less than 35° F. need to be achieved, the circulating fluid system would not work. Circulating systems are not able to alter the speed of increase or decrease in temperature as rapidly as direct treatment.
Current direct TEM treatment devices have overcome many of the issues related to fluid, but do not achieve some of the issues related to thermal treatment. One of the issues is ensuring that treatment is carried out as prescribed by the professional recommending treatment.
For acute injuries, e.g., strains, sprains, minor tears, trainers and other professionals recommend 15 to 30 minutes of ice treatment followed by 30 to 45 minutes off continuously during waking hours for the first 24 to 72 hours depending on the severity and improvement speed of the patient. Very few patients maintain consistency in the process simply because it is not practical.
With the advent and continued advancements of solid state circuitry and improved microprocessors, controllers can be miniaturized and still managing many actions. With apps for handheld devices, and wireless capabilities, we now can communicate in ways that were not available just a few years ago.
New thermal treatment devices can now use these technologies to ensure that recommended treatment is completed as recommended and that actual results and use can be maintained and recorded for review and corrective action. Ensured treatment may lead to shortened recovery.
Additionally, improved thermal qualities of the substrate used to remove or transmit heat from the site, will have a significant impact on speed of penetration and control of the temperature of the thermal device.